Pharmatension: Demystifying The Zimmermann Patent
Updated: May 6
Indian law has been ever evolving and has witnessed an increasing number of Intellectual Property related disputes. Patent is one of the common protections for inventions and the rights associated thereto. The Indian Patent Act was amended in 2005 to suit the guidelines of the TRIPS Agreement. This case is a great example for showing how inventions and mere discoveries differ in the eyes of the Indian Patent Laws. The basic requirement for obtaining a patent is to fulfill the three-fold test of uniqueness, innovativeness and industrial applicability. The Laws with regard to pharmaceuticals have a low level of inventiveness required to patent a product but further it shall be seen that what is the bare minimum amount of inventiveness required for the same [i]. In light of the same, the instant case is one that deals with the amendment to the law and the substitution of Section3(d), in the 2005 Amendment and how it took into consideration the issue of inventiveness in pharmaceutical patents.
Patent can be seen as a monopoly right that would be conferred to the one who invents such product. This acts as a form of incentive to the inventors and also facilitate the research and development in varied field of work especially in the field of science[ii].
Jurg Zimmermann was an inventor of a number of derivatives of n-phenyl-2-pyrimidine-amine, of which is CGP57148 in free base form which later obtained an International no-proprietary name from the world health organization and came to be known as Imatinib. All the derivatives including that of Imanib are capable to inhibit protein Kinases especially protein Kinase C and PDGF(platelet derived growth factor)-receptor tyrosine Kinase and thus have valuable anti-tumor properties which is immensely useful for preparing pharmaceutical compositions to treat warm blooded animals, such as anti-tumoral drugs and as drugs against atherosclerosis.
The n-phenyl-2-pyrimidine-amine derivatives including Imanib were submitted for patent in the United States of America, the application was made on 28th April,1994 and the patent was granted on 28th May,1996 and was known as the "Zimmermann Patent" the Zimmerman compounds were also granted a European Patent[iii].
The Imatinib in its free base form as the "e-duct" in a two stage invention first produced its methane sulphonic acid addition salt Imatinib Mesylate, there after proceeding to develop the beta crystalline form of the salt of Imatinib. Starting from Imatinib free base, one could reach the the beta crystal form of Imatinib mesylate in two ways, one by digesting another crystal form especially the alpha crystal form or an amorphous starting material of the methane sulphonic acid addition salt of compound of formula one and second by disolving another crystal form especially the alpha crystal form or an amorphous starting material of the methane sulphonic acid addition salt of compound of formula one.
Novartis, a Swiss based company dealing in pharmaceuticals, filed an application to grant patent in the year 1997, for an anti-cancer drug 'Glivec ' which could be used to treat Chronic Myeloid Leukemia and Gastrointestinal Stromal Tumors. The basis of the patent being that they had invented the beta crystalline form of Imatinib which is known to be Imatinib Mesylate. At this point time India did not grant patent to pharmaceutical and agrochemical products. In the year 2005, India started to patent such products in compliance with the TRIPS Agreement by revising its patent laws. Novartis' application was put in the mail-box procedure till January 1, 2005 and then taken up for consideration once the Indian Patent Laws were made in compliance of the TRIPS agreement. The claim by Novartis was that they invented a new compound from one of the Zimmermann Patents.
Novartis claimed that the compound had enhanced efficacy with respect to the flow of properties, thermodynamic stability and 30 % increased bioavailability. The patent office rejected the application on the basis of the pre-grant oppositions which reasoned that Novartis did not pass the test of obviousness to a person skilled in the art and novelty and could not be considered as an invention in light of Section 3(d) of The Patent Act.
The Applicant preferred an appeal before the Madras High Court. They contended that Section 3(d) was unclear, ambiguous, violative of Article 14 of the Indian Constitution and was not in harmony with the TRIPS Agreement. They also contended for the reversal of the judgment of the patent controller's office. The application was rejected in the year 2007 and then transferred to the Intellectual Property Appellate Board (IPAB)[iv]. IPAB also denied the patent and then Novartis filed a Special Leave Petition under Article 136 of the Indian Constitution in the Supreme Court in 2009. The Supreme Court did not consider any of the aforementioned decisions and started hearing the case afresh.
The Apex court primarily took up the matter of the product being an invention or not. According to the Act, Section 2(j), an invention is a new product or process involving an inventive step and shall be capable of industrial use. The court opined that the beta form of Imatinib Mesylate is not an invention as it is found to be obvious to have knowledge about the compound if one is skilled in knowing the Zimmermann Patent. The court held that neither Imatinib nor Imatinib Mesylate was an invention nor was it patentable. The court held that Section 3(d)of the Act states that the "mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant [v] and hence, the product does not satisfy the test of Section 3(d). The court held that the patent could not be granted as it was just a modification to an already known compound.
The Court observed that the product was one of the new forms of the substance and was not a different or a whole new substance by itself. It could be seen that it existed in the original amorphous form. The product does not satisfy the test of Section 3(d). Further, the section specifies that a new form of the product is not patentable unless it is known to have enhanced the "known efficacy"[vi].
Thus, the Apex Court rejected the contention stating that in cases of medicines efficacy means therapeutic efficacy. Further, it was stated that the applicant has the liability to prove that the product has therapeutic efficacy based on research data in vivo in animals[vii].
The judgment delivered by the Supreme Court is one which pertains to a greater cause. It can be seen that large pharmaceutical companies use the patent to monopolize the market. This act gives them the power to control the greater part of the market allowing them to set the prices as per their will. This unreasonable act would in turn result in only a part of the population to derive benefit from the product due to a predatory pricing. India is a developing country and the Supreme Court kept in mind the availability of the medicine to the common masses and not only to the more affluent part of the society. The Indian law for Patent is thus justified to prohibit the liberal approach of granting patents and having a rigorous procedure to grant patents only to genuine inventions[viii].
Shining light on a few aspects of the case it can be seen that the decision of the Supreme court might have overlooked a few key factors in the case. Primarily, the patent was denied as the product was a modified form of the Imatinib. It has to noted that the Zimmermann patent only specifically mentions 37 compounds, but the making of the beta form of Imatinib Mesylate is not an obvious or predictable feat, although it is a derivative form of the parented compound. As stated above in the paper it can be seen it is a complicated ten step process divided in two stages. The court has taken a more subjective approach when it denied the patent. The judgment was made for the greater good of the society but it missed the key front on the case. Section 3(d) was explained and the broad aspects of it was also laid down but the obviousness of the feat as opined by the court was not truly that obvious.
[i] Dr. VK Ahuja, Law Relating to Intellectual Property Rights, Third Edition, 2017; Lexis Nexis, Gurgaon, Pg- 482-488.
[ii] Dr. Mathew Thomas; Understanding Intellectual Property; 1st Edition 2016; Eastern Book Company, Lucknow; Pg-218.
[iii] N.S. Gopalakrishnan & T.G. Agitha ; Principles of Intellectual Property; 2nd Edition 2014; Eastern Book Company, Lucknow; Pg-70-71.
[iv] Novartis AG vs. Union of India Misc. Petition Nos. 1 to 5 of 2007 in TA/1 to 5/2007/PT/CH.
[v] “For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy”, Section 3(d) of Patent Act,1970.
[vi] Bayer Corporation vs. Union of India Writ Petition No. 1323 of 2013 (Bombay High Court).
[vii] Novartis A.G. vs. Union of India (2013) 6 SCC 1.
[viii] Dr. Mathew Thomas; Understanding Intellectual Property; 1st Edition 2016; Eastern Book Company, Lucknow; Pg-218.
Atish Chakraborty (BA LL.B, Sem 9, ALSK)
Debdeep Das (BALLB Sem 5, ALSK)